An affordable eQMS platform

Scales from a few users to 2000+

Document-Controls
Document controls

Document controls

Bring order to your development, ensure documents are created, approved, distributed, indexed, and archived in a solid and systematic way.

Version control

Change management

Audit trails

Configurable approval workflows

Metadata indexing

Integrated e-signatures (FDA 21 CFR Part 11 compliant)

Design-Controls
Design controls-icon-1

Design controls

Gather and control your design inputs and outputs in one place, stage gate your processes to continually validate designs and manage risk. Automate and bulletproof your design documentation for frictionless compliance:

Flexible phase gating

Design validation

Assemble FDA technical documentation in real-time (DHF, DHR, DMR)

Quality-Modules
Quality modules

Quality modules

A configurable suite of features to manage your quality processes to drive continuous improvement and seamless regulatory compliance:

Training matrices

Complaints handling

Non-conformance reports

CAPA forms

Post market surveillance

Compliance
Compliance

Compliance

All the tools you need to gain ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, but flexible and configurable. Cognidox helps compliance become the ‘way you do things’.

Assemble required technical documentation in real-time

Publish DHF, DHR and DMR on demand

Integrate FDA compliant E-signatures

CAPA reporting built around the way you work

Software validation

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Document management software tailored to your business

Providing improved visibility and control for the development process for Semiconductors and medical device businesses.

Medical Devices

A flexible eQMS platform designed for your medical device development or IVDR compliance. Validated for ISO 13485 with quality modules, eSignatures and training matrixes built in.

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High Tech Products

Our Lean DMS brings you centralised control and oversight. It ensures your product development process is consistent, sustainable, and continually improving.

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Med Dev Consultants

A single platform on which you can provide unlimited clients with their own individual eQMS. You can clone a QMS structure and templates to have your clients set up in minutes.

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Cognidox delivers from day one

Cognidox helps you rapidly migrate from paper, Google Docs or OneDrive, to a structured document management system. We’ve helped hundreds of businesses bring their documents and process under control, helping them innovate faster and repeat development success time and again.

Quick & easy to implement

Quick & easy to implement

Minimises risk-icon

Minimises risk

Cost effective

Cost effective

Don't just take our word for it!

We are consistently rated outstanding by ISO, and I attribute 80% of that to the structure that Cognidox brings.

Jonathan Jeacocke, VP of Technology at DisplayLink

The software is very intuitive and configurable. The Cognidox team is friendly and approachable, and understands our needs. All in all, a powerful offering.

David Ahern, CEO at Coalesce Product Development

Once you get your head around it, the system is easy to use. Great audit trail and access control.

Morag McFarlane, CEO at Niche CRO

User-friendly and very good customer support.

Sateesh Bisabathuni, Technical Director at Camallergy

Cognidox is by far the easiest eDMS/eQMS to use and scores with a full-equipped access, without the need to buy/install/grant access to different modules. In addition, Cognidox is independent of any file-type and does not use thrid-party "logic", such as MFiles or alike.

Guenter Duerr, Director at Capsero

Cognidox has transformed our QMS by having one easy-to-use system for all our teams to access, and saving us time with the manual processes of document control and scheduling.

Claire Raeburn, Quality Compliance Manager at Tissue Solutions

What’s great is Cognidox doesn’t require you to work in a particular way. You can decide how you want to run your engineering,  development or quality flows. Rather than imposing a way of doing things, Cognidox supports the way you want to do it.

Ian Stacy, VP Operations at Display Link

Cognidox is easy to use and simplifies processes! The support and training provided are fantastic

Julie Errington, Clinical Trials Manager at NCCPG

It is a joy to configure and work with the system on a daily basis. There are new features implemented frequently. If I had the chance to develop a DMS, it would most likely be like Cognidox.

Orsolya Szabo, Quality Manager at Kandou Bus

A great value product with excellent features and unparalleled support.

Trevor Gainey, Quality Consultant

Cognidox was introduced as a mandate, but it grew organically throughout the company, as users began to realise it could solve more problems.

Rupert Baines, CEO at UltraSoc

The search facility sits at the top of the interface at all times and is extremely powerful and quick, and the advanced search facility is excellent.

David Ahern, CEO at Coalesce Product Development

Just wanted to say what great support Cognidox provides - questions are answered promptly and difficulties are always overcome.

Martin J, Group Head of Technology in UK
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How do we work with you?

Four steps to a better DMS:

Starting with an obligation-free demo, if we’re the right fit for you we’ll offer a 60 day free trial of our platform. When you choose us as your partner, we’ll help you migrate data and configure the platform, with a dedicated account manager to look after you as you grow.

Demo

See if Cognidox can help you by scheduling a no-obligation, tailored demo

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Live Trial

Set up a free 60 day live trial to test the solution with real users and processes

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Onboard

We’ll help you configure your system, migrate your data and train your team

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Support

A dedicated Account Manager will support you as you scale (our average response time is under 20 minutes)

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Experience Cognidox

Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.

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